Cantel Medical MEDIVATORS renatron II 100 Series Instruction Manual
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Cantel Medical MEDIVATORS renatron II 100 Series Instruction Manual

Dialyzer reprocessing system
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100 Series Dialyzer Reprocessing System
INSTRUCTION MANUAL
MODEL RS 8330 & RS 8335
100 Series

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Summary of Contents for Cantel Medical MEDIVATORS renatron II 100 Series

  • Page 1 100 Series Dialyzer Reprocessing System INSTRUCTION MANUAL MODEL RS 8330 & RS 8335 100 Series...
  • Page 2 RENATRON , RENALIN , PERASSAY , ACTRIL and ON-DEMAND are registered trademarks of Medivators Inc. ® ® ® ® ® Formula 409 is a registered trademark of the Clorox Company. ® 50096-725 Rev D © 2015 Medivators Inc. Printed and Assembled in the United States. All Rights Reserved.

  • Page 3: Table Of Contents

    Contents Section Topic Indications Contraindications Warnings and Precautions Description Specifications Description of Controls RENATRON II 100 Series Installation Instructions ® Computer Installation Instructions Daily Machine Sanitize Procedure Operating Procedures Bar Code Scanner Procedures: Storage and Handling for Reprocessed Dialyzers Calibration and Adjustment RENATRON II 100 Series Calibration Procedure Maintenance Service...

  • Page 4: Indications

    Read this Manual and the RENALIN 100 Cold Sterilant Instructions for Use prior to ® using the RENATRON II 100 Series Dialyzer Reprocessing System. Failure to follow the ® instructions for use may result in injury. Retain this manual for future reference. CAUTION - ONLY HOLLOW FIBER DIALYZERS SHOULD BE PROCESSED AS SPECIFIED IN THIS MANUAL.

  • Page 5: Description

    WARNING ELECTRIC SHOCK HAZARD: ONLY QUALIFIED PERSONNEL SHOULD REMOVE TOP COVER. CAUTION – DO NOT OPERATE THE RENATRON II 100 SERIES MACHINE WITH THE COVER OFF UNLESS ® SPECIFICALLY INDICATED IN THIS MANUAL. CAUTION – ALL PERSONNEL USING THIS DEVICE SHOULD BE FAMILIAR WITH THE INFORMATION CONTAINED IN THIS MANUAL.
  • Page 6 3. Materials for interconnection of the RENATRON II 100 Series System: ® a. RENATRON II 100 Series station to Interface Module communication cable(s) b. Computer to Interface Module communication cable (1 ea.) c. Computer to Printer communication cable (2 cables) 4.
  • Page 7 CAUTION – IN THE EVENT A DIALYZER HAS BEEN LEFT ON THE MACHINE AND DOUBT EXISTS WHETHER VENT ACTION HAS OCCURRED, (I.E. POWER FAILURE TO RENATRON II 100 SERIES) THE DIALYZER MUST BE REMOVED CAREFULLY. REMOVE THE DIALYZER AFTER WRAPPING ALL CONNECTIONS WITH DISPOSABLE ABSORBENT MATERIAL.

  • Page 8: Specifications

    e. Operator presses the "OFF" switch, and allows the machine to sit for a minimum of 6 hours before using again. NOTE – A sanitize holding period of six hours or more will expose the machine’s fluid pathways to Proportioned RENALIN 100 Solution for a time consistent with the disinfection time indicated in the RENALIN 100 Cold ®...
  • Page 9 D. Physical Properties and Dimensions: 1. RENATRON II 100 Series station: Width 14.5 inches 41 cm Depth 12.3 inches 31 cm Height 16 inches 33 cm Weight 50 lbs 23 kg 2. Interface Module: Width 12 inches 30.5 cm Depth 11 inches 28 cm Height...
  • Page 10 E. Environmental Limits: The RENATRON II 100 Series is designed to be safe for indoor use at temperatures from 5˚C (41˚F) to 40˚C ® (104˚F), maximum relative humidity of 80% at 31˚C (87.8˚F) decreasing linearly to 50% relative humidity at 40˚C (104˚F).

  • Page 11: Description Of Controls

    I. Chemicals Required: The RENATRON II 100 Series station is designed to function with RENALIN 100 Cold Sterilant. This ® solution is described in the RENALIN 100 Cold Sterilant Instructions for Use (P/N 50090-679). ® A. RENATRON II 100 Series Station Controls (Figure 1) Description 1.

  • Page 12: Renatron ® Ii 100 Series Installation Instructions

    3. "TANK VOLUME" error message appears when the internal mixing/measuring tank should be empty but is not or when an improper action has occurred within the tank. 4. "CLEAN" message appears during the dialyzer cleaning steps. 5. "ADD CHEMICAL" error message appears when machine detects that an insufficient amount of RENALIN ®...
  • Page 13 Figure 1 RS-8335 Instruction Manual -13-...
  • Page 14 Figure 2 RS-8330 Instruction Manual -14-...
  • Page 15 CAUTION – ALWAYS STORE THE RENALIN 100 COLD STERILANT CONTAINER UPRIGHT AND OUT OF ® DIRECT SUNLIGHT. EXPOSURE TO DIRECT SUNLIGHT DAMAGES THE CLEANING AND DISINFECTING QUALITIES OF THE RENALIN 100 COLD STERILANT. NOTE - STORING RENALIN 100 COLD STERILANT IN ITS ORIGINAL SHIPPING CARTON PREVENTS EXPOSURE TO SUNLIGHT.

  • Page 16: Computer Installation Instructions

    Computer B. Computer systems includes: Installation 1. Desktop computer Instructions 2. Color monitor 3. Printer(s) 4. Interface module 5. Bar code scanner 6. Interconnecting cables C. Place the computer, monitor, and printer in desired location on a sturdy bench or counter top away from the RENATRON II 100 Series Station's wet area (or protected from fluid spray).

  • Page 17: Daily Machine Sanitize Procedure

    Daily A. The RENATRON II 100 Series station must be sanitized once each day. Perform the following procedure ® at end of reprocessing day: Machine 1. Ensure that the RENALIN 100 container has at least 1" of unexpired RENALIN 100. ®...
  • Page 18 COMPUTER MONITOR LABEL MOUSE PRINTER REPORT KEYBOARD VIDEO PRINTER LPT 1 MOUSE KEYBOARD COM 1 COM 2 BARCODE SCANNER BARCODE SCANNER INTERFACE MODULE INTERFACE MODULE Port 6 Port 5 Port 4 SCANNER Port 6 Port 5 Port 4 SCANNER Port 3 Port 2 Port 1 COMPUTER...
  • Page 19 WARNING THE PROPORTIONED RENALIN 100 SOLUTION CONTAINED IN THE ® REPROCESSED DIALYZER MUST BE ADEQUATELY AND THOROUGHLY RINSED OUT OF THE DIALYZER PRIOR TO ITS CLINICAL USE. THIS SHOULD BE DONE IN ACCORDANCE WITH THE INSTRUCTIONS SET FORTH IN THE RENALIN 100 COLD STERILANT INSTRUCTIONS FOR USE (PART #50090-679).
  • Page 20 CAUTION – IT IS THE SOLE RESPONSIBILITY OF THE PRESCRIBING PHYSICIAN TO DETERMINE THE ACCEPTABLE BLOOD COMPARTMENT REFERENCE VOLUME AND PROGRAM MODE FOR A PARTICULAR TYPE AND SIZE HOLLOW FIBER DIALYZER. THIS REFERENCE VOLUME AND PROGRAM MODE MUST BE SET FROM THE FRONT PANEL MANUALLY OR INITIALLY ENTERED INTO THE DATABASE TO ALLOW THE COMPUTER TO AUTOMATICALLY SET THESE VALUES BEFORE REPROCESSING A DIALYZER.
  • Page 21 Note – The amount of processed and failed dialyzer labels can be specified in the Administrators Mode of the RENALOG RM program. ® 5. If a "VOLUME FAIL" or "PRESSURE FAIL" message appears, press the "START PROCESS" switch to perform the test again. The dialyzer may pass when retested by the RENATRON II 100 Series station.
  • Page 22 9. Disconnect the "VENOUS OUTLET" line from the reprocessing connector attached to the dialyzer venous blood port. Remove the reprocessing connector and place it in fresh 1% RENALIN 100 Solution or full strength Actril Cold Sterilant for a minimum of thirty (30) minutes. 10.

  • Page 23: Bar Code Scanner Procedures

    Bar Code J. Bar code scanning procedure Scanner 1. Aim the red illuminated beam of the scanner directly above the bar code. The red beam should be parallel to the bar code and the gun should be held 6 to 9 inches from the bar code. Procedures: 2.

  • Page 24: Storage And Handling For Reprocessed Dialyzers

    Storage and A. The storage area should be a well-ventilated, cool area that is out of direct sunlight. Handling for B. Reprocessed dialyzers should not be exposed to freezing temperature or sources of heat. The recommended temperature range is 59˚F (15˚C) to 75˚F (24˚C). Reprocessed WARNING Dialyzers...

  • Page 25: Renatron Ii 100 Series Calibration Procedure

    RENATRON This procedure should be used if your RENATRON II 100 station has a board with three white buttons ® used for calibration. 100 Series Note — You should complete steps 4-6 within 60 seconds. If you do not complete the sequence within 60 seconds the Calibration Renatron II 100 station will return to an idle mode.
  • Page 26 NOTE – The new calibration values are not saved until you complete step 10 and exit the calibration mode. 11. Press the "MUTE" and "RESET" switches together until program "(00)" is displayed. 12. Press the "HOLD TO SET" switch while adjusting the "SET" knob to display a volume greater than 200 in the "VOLUME"...

  • Page 27: Maintenance

    Maintenance The following procedures will help maintain peak performance of the RENATRON II 100 Series Dialyzer Reprocessing ® Station. If at any time during this process you have a question or concern, please contact MEDIVATORS Renal Technical Support for additional information. Exterior Inspection - the RENATRON II 100 Series Station should be inspected periodically for any defects such as the following: Bent or broken switches...
  • Page 28 3. Place the uptake tube into a container of purified water (one gallon or more). 4. Connect external hoses in sanitize configuration. 5. Turn on the RENATRON II 100 Series Station. Press the "MUTE ALARM" and "RESET" switches to ® change to the "HF"...
  • Page 29 22. Press the "ON" switch, select program, "(00)," and press the "START SANITIZE" switch. Allow the machine to operate to completion of PROGRAM STEP 75 and press "OFF" switch (No problems will occur if machine operates past step 75 before turning off). This action clears the water from the uptake hose and replaces it with RENALIN 100 Cold Sterilant.
  • Page 30 D. Culture Sample Collection RENATRON stations - RS-8335 ® Water culture samples can be easily collected from the RENATRON station by first running the RENATRON Water Culture Sample Cycle. 1. Prepare the RENATRON for sample collection a. Ensure that the RENATRON was sanitized with the calibration cell in place, allowed to dwell for at least 6 hours, and was undisturbed since the initiation of the Sanitize Cycle.

  • Page 31: Service

    Service Note – Pressing the "START PROCESS" switch while RENATRON II 100 Series station is turned on and is holding in Step 83 will result in a 10 minute hold in Step 84 with subsequent water rinse and air purge of hydraulic pathway. CAUTION –...
  • Page 32 RENATRON II 100 DIALYZER REPROCESSING ® STATION PERFORMANCE INSPECTION SCHEDULE Monthly Intervals Inspection Description Calibration Verification Performed daily by the operator RENATRON Exterior Inspection Performed daily by the operator ® Formula 409 cleaning procedure Perform this procedure every ® 2 weeks or as needed Inspect all external Quick Disconnects for defects and/or worn O-rings Inspect Reprocessing Connections...

  • Page 33: Warranties/Limitations

    Warranties/ II 100 Station or any personal injury directly or proximately resulting from any repairs made or attempted to be made by any person other than a factory representative of MEDIVATORS . If MEDIVATORS replaces Limitations non-MEDIVATORS parts the customer will be charged in full for all replaced parts. Limited Warranty Subject to the terms below, Medivators Inc.

  • Page 34: Explanation For Symbols

    Explanation for Attention, consult accompanying documents Symbols Off; power disconnected from the mains On; power connected to the mains Off, connected to mains but in a wait or standby mode On, active state as opposed to standby Dangerous voltages within equipment IPX1 Drip-proof equipment As Operator Accessible Fuse Location...

  • Page 35: Part Number Listings

    Part Number Item Part Number Listings RENALOG RM Instruction Manual 50090-859 ® PERASSAY 500 Directions for Use 50086-010 ® RENALIN Residual Test Strips 50083-000 ® Directions for Use RENATRON Service Manual 50101-000 ® RENALIN 100 Cold Sterilant (without kit) 78397-844 RENALIN 100 Cold Sterilant (1 test kit) 78397-845 RENALIN 100 Cold Sterilant (3 test kits)
  • Page 36 Manufactured in the USA by: Medivators BV Cantel Medical Asia/Paci c Pte. Ltd. Cantel Medical Devices (China) Co. Ltd. Medivators Inc. Sourethweg 11 1A International Business Park Unit 804-805, Innov Tower Block A, 14605 28th Avenue North 6422PC Heerlen #05-01 Singapore 609933...

This manual is also suitable for:

Rs 8330Rs 8335

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